Prior Authorization Criteria — Voxzogo (vosoritide)
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Prior authorization criteria and approval rules for Voxzogo (vosoritide) for pediatric patients with achondroplasia as administered by the West Virginia Bureau for Medical Services. Applies to providers seeking PA for this drug under the WV Medicaid program.
No material clinical or coverage changes in this revision.
Coverage Criteria for Voxzogo (vosoritide)
Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met
Initial approval duration: 3 months
Initial authorization — Initial authorization requirements and duration
Initial authorization requirements and duration
Initial approval will be for 3 months
Continuation Therapy / Reauthorization — Reauthorization requires ALL of the following
Reauthorization requires ALL of the following
Continuation of therapy will be granted for 12 months
Reauthorization — Reauthorization requirements for continuation of therapy
Reauthorization requirements for continuation of therapy
Voxzogo (vosoritide) must not be used concurrently with any human growth hormone products. Additionally, patients who have undergone limb-lengthening surgery within the prior 18 months, or who plan to receive limb-lengthening surgery during treatment, are excluded from therapy. These restrictions are part of the coverage criteria and are required to be documented at initial authorization and reassessment.
Providers should confirm absence of recent or planned limb-lengthening surgery in submitted documentation and must not prescribe Voxzogo alongside growth hormone treatments; failure to meet these exclusion criteria may result in denial of prior authorization.
Coding and Imaging Requirements
Provider Actions, Documentation, and Authorization
Prior authorization required; initial and reauthorization durations
Prior authorization is required for Voxzogo. Initial approval will be granted for 3 months when all listed initial criteria are met. Reauthorization requires documentation of continued compliance, evidence that epiphyses remain open, and documented improvement in growth velocity compared to pre-treatment baseline; when those reauthorization criteria are met continuation will be granted for 12 months.
- Initial approval duration: 3 months
- Reauthorization (continuation) duration: 12 months
No step therapy required
No step therapy requirements are specified for Voxzogo.
Required clinical documentation to support PA and reauthorization
Providers must submit clinical documentation with the prior authorization request including genetic testing confirming achondroplasia, x‑ray confirmation of non-closure of epiphyseal plates when required by age, baseline and ongoing measurements of height, weight, growth velocity, and physical development, and documentation that the patient has not had limb-lengthening surgery in the prior 18 months and none is planned during treatment. For reauthorization, provide documentation of continued compliance, evidence that epiphyses remain open, and documentation of improved growth velocity versus the pre-treatment baseline.
- Genetic testing confirming achondroplasia
- X‑ray evidence of non-closure of epiphyseal plates for females >12 years and males >14 years
- Baseline and ongoing height, weight, growth velocity, and physical development measurements
- Documentation of no limb-lengthening surgery within the previous 18 months and none planned during treatment
- For reauthorization: evidence of continued compliance and improved growth velocity vs pre-treatment baseline
Denial risk if approval criteria are not met
Requests may be denied if the patient does not meet all approval criteria — for example, if the patient is outside the FDA-recommended age range, lacks genetic confirmation of achondroplasia, the prescription is not from a pediatric endocrinologist, required x‑ray evidence shows closed epiphyses, there is recent or planned limb‑lengthening surgery within 18 months, or Voxzogo is prescribed in combination with human growth hormone products.
- Age not within FDA label/indication
- No genetic confirmation of achondroplasia
- Prescriber is not a pediatric endocrinologist
- X‑ray shows closure of epiphyseal plates when openness is required
- Limb-lengthening surgery within prior 18 months or planned during treatment
- Concurrent use with human growth hormone products
Background and Indication
Voxzogo (vosoritide) is a C-type natriuretic peptide analog indicated to increase linear growth in pediatric patients with achondroplasia who meet the FDA-recommended age criteria and have open epiphyses. Approval requires genetic confirmation of achondroplasia, prescription by a pediatric endocrinologist, and baseline and ongoing monitoring of height, weight, growth velocity, and physical development.
The FDA granted approval under an accelerated pathway based on improvement in annualized growth velocity. Continued coverage requires documented benefit (improved growth velocity versus pre-treatment baseline) and ongoing demonstration of open epiphyses where age-based x-ray confirmation is required.
Definitions
Initial Therapy Criteria
Initial authorization — Initial authorization requirements and duration
Initial authorization requirements and duration
Initial approval will be for 3 months
Continuation / Reauthorization Criteria
Reauthorization — Reauthorization requirements for continuation of therapy
Reauthorization requirements for continuation of therapy
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